U.S. patent application number 12/409094 was filed with the patent office on 2009-10-15 for loop suture.
Invention is credited to Matthew D. Cohen.
Application Number | 20090259251 12/409094 |
Document ID | / |
Family ID | 40852372 |
Filed Date | 2009-10-15 |
United States Patent
Application |
20090259251 |
Kind Code |
A1 |
Cohen; Matthew D. |
October 15, 2009 |
LOOP SUTURE
Abstract
The present disclosure relates to a suture having a proximal end
defining a first outer diameter and a distal end configured to
accommodate the proximal end of the suture to form a closed loop
stitch.
Inventors: |
Cohen; Matthew D.; (Berlin,
CT) |
Correspondence
Address: |
Tyco Healthcare Group LP
60 MIDDLETOWN AVENUE
NORTH HAVEN
CT
06473
US
|
Family ID: |
40852372 |
Appl. No.: |
12/409094 |
Filed: |
March 23, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61044131 |
Apr 11, 2008 |
|
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Current U.S.
Class: |
606/228 |
Current CPC
Class: |
A61B 17/06166 20130101;
A61B 2017/00867 20130101; A61B 2017/00951 20130101; A61B 2017/06185
20130101; A61B 2017/00004 20130101; A61B 2017/06176 20130101 |
Class at
Publication: |
606/228 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A suture comprising: an elongate body having a proximal end and
a distal end, the proximal end having a first outer diameter, and
the distal end having an inner hollow region with an inner diameter
which is configured to receive at least a portion of the first
outer diameter of the proximal end of the suture.
2. The suture of claim 1 wherein the suture comprises a
monofilament.
3. The suture of claim 1 wherein the suture comprises a
multifilament.
4. The suture of claim 1 wherein the suture comprises a
bioabsorbable material.
5. The suture of claim 1 wherein the suture comprises a
non-bioabsorbable material.
6. The suture of claim 1 wherein the suture forms a closed
loop.
7. The suture of claim 1 wherein the distal end of the suture is
flared.
8. The suture of claim 1 wherein the distal end of the suture has a
second outer diameter that is greater than the first outer diameter
of the proximal end of the suture.
9. The suture of claim 1 further comprising at least one slot on
the distal end of the suture to allow at least a portion of the
proximal end of the suture to be received by the distal end of the
suture.
10. The suture of claim 9 further comprising a plug engaged to at
least one of the slots of the flared distal end, wherein the plug
is dimensioned to frictionally fit within the slot of the distal
end of the suture.
11. The suture of claim 1 wherein the proximal end of the suture is
hollow.
12. The suture of claim 1 wherein the suture is hollow.
13. The suture of claim 1 wherein the proximal end of the suture
further comprises a pointed tip for penetrating tissue.
14. The suture of claim 13 wherein the pointed tip is a surgical
needle.
15. The suture of claim 13 wherein the pointed tip is made from a
material selected from the group consisting of stainless steel,
shape memory alloys, metal alloys and combinations thereof.
16. The suture of claim 1 wherein the suture further comprises at
least one external friction-enhancing member.
17. The suture of claim 16 wherein the external friction-enhancing
member is selected from the group consisting of barbs, grooves,
treads, bumps, ridges, adhesives and combinations thereof.
18. The suture of claim 16 wherein the external friction-enhancing
member is positioned on the proximal end of the suture.
19. The suture of claim 1 wherein the suture further comprises at
least one internal friction-enhancing member.
20. The suture of claim 19 wherein the internal friction-enhancing
member is selected from the group consisting of barbs, grooves,
treads, bumps, ridges, adhesives and combinations thereof.
21. The suture of claim 19 wherein the internal friction-enhancing
member is positioned in the inner hollow region of the distal end
of the suture.
22. A suture comprising: an elongate body having a proximal end and
a distal end, the proximal end having a first outer diameter, and
the distal end having a second outer diameter and an inner hollow
region defining an inner diameter within the distal end, wherein
the distal end is configured to receive at least a portion of the
first outer diameter of the proximal end.
23. A method of suturing tissue comprising: providing a suture
having a proximal end with a first outer diameter and a distal end
having an inner hollow region with an inner diameter which is
configured to receive at least a portion of the first outer
diameter of the proximal end of the suture; and passing the
proximal end of the suture through the tissue; and engaging the
distal end of the suture with at least a portion of the proximal
end of the suture and forming a closed loop.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of and priority
to U.S. Provisional Application Ser. No. 61/044,131, filed on Apr.
11, 2008, the entire disclosure of which is incorporated herein by
reference.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure relates to sutures and more
particularly to sutures which include a proximal end having a first
outer diameter and a distal end having an inner hollow region with
an inner diameter which is configured to accommodate at least a
portion of the first outer diameter of the proximal end of the
suture to form a stitch.
[0004] 2. Background of Related Art
[0005] Sutures are well known for tying approximated tissues of a
wound together at intervals along the length of the wound. Although
sutures have been proven to sufficiently close a wound, the process
can be somewhat time consuming depending upon the handling
characteristics of the suture and the wound location. For example,
some suture materials are not easily tied into knots, or can not
withstanding the constant movement through tissue when closing a
larger wound and as a result break in the middle of the suturing
process.
[0006] There are great advantages in providing a suture capable of
closing a wound in tissue following surgery, i.e., plastic,
general, or laparoscopic, which eliminates the need for tying a
knot and also forms individual stitches thereby exposing the suture
to less stress and decreasing the likelihood of the suture breaking
before the wound is closed.
SUMMARY
[0007] Accordingly, the present disclosure describes sutures which
include an elongate body that has a proximal end and a distal end.
The proximal end has a first outer diameter and the distal end has
an inner hollow region with an inner diameter which is configured
to receive at least a portion of the first outer diameter of the
proximal end of the suture.
[0008] In embodiments, the sutures have an elongate body that has a
distal end and a proximal end. The proximal end has a first outer
diameter, and the distal end has a second outer diameter which is
greater than the first outer diameter of the proximal end. The
distal end further includes an inner hollow region defining an
inner diameter within the distal end which is configured to receive
at least a portion of the first outer diameter of the proximal end.
Methods of suturing tissue are also described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] Various embodiments are illustrated and described herein,
wherein:
[0010] FIG. 1A is a side view of a suture containing a distal end
having an inner hollow region defined therein in accordance with
one embodiment of this disclosure;
[0011] FIG. 1B is a side view of a suture containing a tip in
accordance with one embodiment of this disclosure;
[0012] FIG. 2A is a side view of a suture containing at least one
slot in accordance with one embodiment of this disclosure;
[0013] FIG. 2B is a side view of a suture forming a closed loop
stitch in accordance with one embodiment of this disclosure;
[0014] FIG. 2C is a side view of a suture containing a distal end
having an inner hollow region defined therein including internal
friction-enhancing members.
[0015] FIG. 3 is a side view of a suture containing a plug in
accordance with one embodiment of this disclosure; and
[0016] FIGS. 4A-4C are side views of a suture containing a distal
end having an inner hollow region defined therein including
friction-enhancing members.
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0017] Turning now to FIG. 1A, suture 10 is shown as a hollow
monofilament having an elongate body which includes a proximal end
20 defining a first outer diameter 25 and a distal end 30 defining
a second outer diameter 35 which is greater than or equal to first
outer diameter 25. Distal end 30 also includes hollow region 40
defining an inner diameter 45 of distal end 30 which is configured
to receive at least a portion of first outer diameter 25 of
proximal end 20 of suture 10 to form a closed loop stitch. It is
envisioned that suture 10 may be a monofilament or a multifilament
suture (see FIGS. 4A-C) or a combination thereof and proximal end
20 may be hollow or solid or any combination thereof.
[0018] Suture 10 may be made from any material suitable for
manufacturing surgical sutures or ligatures. Suture materials
include for example any bioabsorbable, non-bioabsorbable, synthetic
or natural materials and combinations thereof. Some suitable
examples of absorbable materials include trimethylene carbonate,
caprolactone, dioxanone, glycolic acid, lactic acid, glycolide,
lactide, homopolymers thereof, copolymers thereof, and combinations
thereof. Some specific examples of suitable non-absorbable
materials which may be utilized to form the suture include
polyolefins, such as polyethylene, polypropylene, copolymers of
polyethylene and polypropylene, and blends of polyethylene and
polypropylene. Some other useful materials include nylons, and
cat-gut.
[0019] It is envisioned that the suture described herein may also
be made from biomaterials not commonly associated as suture
materials. Since the sutures are capable of forming a closed stitch
loop which does not require the formation of a knot, these sutures
can be formed of biomaterials which do not possess a minimal
ability to form knots. One example of such a material would include
biomaterials which having a low coefficient of friction. Another
example would include biomaterials displaying a very high
modulus.
[0020] As shown in FIG. 1A, in some embodiments, hollow region 40
is sealed within distal end 30 of suture 10 and is capable of
storing at least one bioactive agent. In these embodiments, hollow
region 40 can also serve as a vehicle for delivery of the bioactive
agent. It is envisioned that at least a portion of proximal end 20
of suture 10 will penetrate into distal end 30 and enter into inner
hollow region 40 to interact with and possibly release a bioactive
agent stored therein. In embodiments where the bioactive agent is
an adhesive, proximal end 20 may be positioned more permanently
within inner hollow region 40 of distal end 30 after reacting with
the adhesive.
[0021] The term "bioactive agent", as used herein, is used in its
broadest sense and includes any substance or mixture of substances
that have clinical use. Consequently, bioactive agents may or may
not have pharmacological activity per se, e.g., a dye, or
fragrance. Alternatively a bioactive agent could be any agent which
provides a therapeutic or prophylactic effect, a compound that
affects or participates in tissue growth, cell growth, cell
differentiation, an anti-adhesive compound, a compound that may be
able to invoke a biological action such as an immune response, or
could play any other role in one or more biological processes. It
is envisioned that the bioactive agent may be positioned on any
part of the sutures described herein. For example, the bioactive
agent may be simply coated on an outer or inner surface of the
suture or combined with the material used to form the suture or may
impregnate the suture surface. In addition, the inner hollow region
may act as a reservoir in storing the bioactive agent. The
bioactive agent may be positioned on the suture in any amount,
configuration, and suitable form of matter, i.e., films, powders,
liquids, gels and the like.
[0022] Examples of classes of bioactive agents which may be
utilized in accordance with the present disclosure include
antimicrobials, analgesics, antipyretics, anesthetics,
antiepileptics, antihistamines, anti-inflammatories, cardiovascular
drugs, diagnostic agents, sympathomimetics, cholinomimetics,
antimuscarinics, antispasmodics, anti-adhesives, hormones, growth
factors, muscle relaxants, adrenergic neuron blockers,
antineoplastics, immunogenic agents, immunosuppressants,
gastrointestinal drugs, diuretics, steroids, lipids,
lipopolysaccharides, polysaccharides, and enzymes. It is also
intended that combinations of bioactive agents may be used.
[0023] Suitable antimicrobial agents which may be included as a
bioactive agent stored within the suture described herein includes
triclosan, also known as 2,4,4'-trichloro-2'-hydroxydiphenyl ether,
chlorhexidine and its salts, including chlorhexidine acetate,
chlorhexidine gluconate, chlorhexidine hydrochloride, and
chlorhexidine sulfate, silver and its salts, including silver
acetate, silver benzoate, silver carbonate, silver citrate, silver
iodate, silver iodide, silver lactate, silver laurate, silver
nitrate, silver oxide, silver palmitate, silver protein, and silver
sulfadiazine, polymyxin, tetracycline, aminoglycosides, such as
tobramycin and gentamicin, rifampicin, bacitracin, neomycin,
chloramphenicol, miconazole, quinolones such as oxolinic acid,
norfloxacin, nalidixic acid, pefloxacin, enoxacin and
ciprofloxacin, penicillins such as oxacillin and pipracil,
nonoxynol 9, fusidic acid, cephalosporins, and combinations
thereof. In addition, antimicrobial proteins and peptides such as
bovine lactoferrin and lactoferricin B may be included as a
bioactive agent in the present disclosure.
[0024] Other bioactive agents which may be included as a bioactive
agent within the sutures described herein include: lubricants;
local anesthetics; non-steroidal antifertility agents;
parasympathomimetic agents; psychotherapeutic agents;
tranquilizers; decongestants; sedative hypnotics; steroids;
sulfonamides; sympathomimetic agents; vaccines; vitamins;
antimalarials; anti-migraine agents; anti-parkinson agents such as
L-dopa; anti-spasmodics; anticholinergic agents (e.g. oxybutynin);
antitussives; bronchodilators; cardiovascular agents such as
coronary vasodilators and nitroglycerin; alkaloids; analgesics;
narcotics such as codeine, dihydrocodeinone, meperidine, morphine
and the like; non-narcotics such as salicylates, aspirin,
acetaminophen, d-propoxyphene and the like; opioid receptor
antagonists, such as naltrexone and naloxone; anti-cancer agents;
anti-convulsants; anti-emetics; antihistamines; anti-inflammatory
agents such as hormonal agents, hydrocortisone, prednisolone,
prednisone, non-hormonal agents, allopurinol, indomethacin,
phenylbutazone and the like; prostaglandins and cytotoxic drugs;
estrogens; antibacterials; antibiotics; anti-fungals; anti-virals;
anticoagulants; anticonvulsants; antidepressants; antihistamines;
and immunological agents.
[0025] Other examples of suitable bioactive agents which may be
included within the suture described herein include viruses and
cells, peptides, polypeptides and proteins, analogs, muteins, and
active fragments thereof, such as immunoglobulins, antibodies,
cytokines (e.g. lymphokines, monokines, chemokines), blood clotting
factors, hemopoietic factors, interleukins (IL-2, IL-3, IL-4,
IL-6), interferons (.beta.-IFN, (.alpha.-IFN and .gamma.-IFN),
erythropoietin, nucleases, tumor necrosis factor, colony
stimulating factors (e.g., GCSF, GM-CSF, MCSF), insulin, anti-tumor
agents and tumor suppressors, blood proteins, gonadotropins (e.g.,
FSH, LH, CG, etc.), hormones and hormone analogs (e.g., growth
hormone), vaccines (e.g., tumoral, bacterial and viral antigens);
somatostatin; antigens; blood coagulation factors; growth factors
(e.g., nerve growth factor, insulin-like growth factor); protein
inhibitors, protein antagonists, and protein agonists; nucleic
acids, such as antisense molecules, DNA and RNA; oligonucleotides;
polynucleotides; and ribozymes.
[0026] Turning now to FIG. 1B, suture 10 is shown to include to a
tip 50 capable of penetrating tissue. In addition, where distal end
30 is closed, tip 50 can serve to penetrate distal end 30 to obtain
access to hollow region 40 and form a closed loop stitch, as shown
in FIG. 1C. In embodiments, tip 50 may be formed from the suture
material. In embodiments, tip 50 may be a surgical needle connected
to the suture material. It is envisioned that suture 10 can be
connected to any suitable surgical needle capable of penetrating
tissue, closing a wound and entering into hollow region 40 of
distal end 30 of suture 10. Some non-limiting examples include
curved needles, straight needles, tapered needles, triangular-body
needles, round body needles, blunt and trocar needles. It is
further envisioned that the sutures described herein may be
attached to a suture needle using any conventional method known to
those skilled in the art including swaging, crimping,
heat-shrinking, adhesives, male/female mating engagement and so
forth.
[0027] In some embodiments, suture 10 may include a tip 50 which is
designed and configured to penetrate through tissue, approximate
tissue and/or close a wound. Tip 50 may be blunt, sharp or any
combination thereof and can be made from any suitable material
capable of penetrating tissue to close a wound. Some useful
examples of suitable materials include, but are not limited too,
metals, such as stainless steels, metal alloys, shape memory
alloys, such as Nitinol, and any shapeable polymeric materials,
such as lactide, glycolide, caprolactone, and the like.
[0028] As shown in FIG. 1B, tip 50 may be preformed and positioned
within proximal end 20 of suture 10. In some embodiments, an
adhesive, such as a cyanoacrylate, may be used to position tip 50
within proximal end 20 of suture 10. In still other embodiments,
tip 50 may be heat-shrunk into position within suture 10.
[0029] In embodiments where tip 50 is made from a shape-memory
alloy, it is envisioned that tip 50 may penetrate hollow region 40
of distal end 30 to form a close-loop stitch and then be exposed to
an electrical, magnetic or temperature force which makes the
shape-memory alloy return to its original shape and dimension which
further tightens the closed-loop stitch creating a tighter and more
secure wound closure.
[0030] Turning now to the embodiment of FIG. 2A, flared distal end
130 of suture 110 is shown to further include slot 160. Slot 160 is
positioned along flared distal end 130 to allow the passage of
proximal end 120 of suture 110 into inner hollow region 140 to form
a closed stitch loop. It is envisioned that slot 160 may be
positioned on any portion of flared distal end 130 to allow entry
of proximal end 120 into inner hollow region 140.
[0031] As shown in the embodiments of FIG. 2B, flared distal end
130 of suture 110 may include more than one slot 160a and 160b to
allow proximal end 120 of suture 110 to penetrate at least a
portion of flared distal end 130 and pass through inner hollow
region 140 before exiting distal flared end 130 through additional
slot 160b. Suture 110 is shown forming a 360.degree. closed loop
stitch. Such a stitch is designed to be formed quickly and does not
necessarily require the use of a knot to keep the wound closed.
Proximal end 120 is shown to include at least one external
friction-enhancing member 125 which is designed to assist in
holding suture 110 in the closed loop position. As shown, external
friction-enhancing members 125 are barbs or barb-like structures
positioned along the outer surface of proximal end 20 of suture 10.
It is envisioned that the external friction-enhancing members may
take any shape or geometric contour suitable for maintaining the
proximal end of the suture within the inner hollow region. Suitable
non-limiting examples include treads, bumps, grooves, spikes,
ridges, and the like.
[0032] In FIG. 2C, inner hollow region 140 of flared distal end 130
of suture 110 is shown further including internal
friction-enhancing members 145. Internal friction-enhancing members
145 may act as a ratchet type mechanism to secure the proximal end
of the suture in the inner hollow region 130 to form a closed loop
stitch. As shown, internal friction-enhancing members 145 are barbs
or barb-like structures positioned along the inner surface of inner
hollow region 130. It is envisioned that the internal
friction-enhancing members may take any shape or geometric contour
suitable for maintaining the proximal end of the suture within the
inner hollow region. Suitable non-limiting examples include treads,
bumps, grooves, spikes, ridges, and the like.
[0033] Turning now to FIG. 3, suture 210 is shown to include a plug
280 which is dimensioned to fit within slot 260. Since slot 260
creates an opening which interconnects inner hollow region 240 with
an outer surface 237 of distal flared end 230, inner hollow region
240 may be unable to store a bioactive agent. Thus, plug 280 is
designed to store at least one of the bioactive agents previously
described herein and release the bioactive agent when penetrated by
proximal end 220 of suture 210, which in some embodiments may
further include a sharpened tip, upon entering or exiting inner
hollow region 240 of distal flared end 230 of suture 210. Plug 280
may be made from any bioabsorbable or non-bioabsorbable
material.
[0034] In the embodiments shown in FIGS. 4A-4C, the sutures are
shown including at least one external friction-enhancing member
and/or at least one internal friction-enhancing member. As shown,
the external members may be added to the outer surface of the
proximal end of the suture, and the internal members mat be
positioned on the inner surface of the inner hollow region of the
distal end of the suture, the inner surface of a slot, or any
combination thereof. In FIG. 4A, a multifilament suture 410 is
shown having an inner hollow region 440 which includes a plurality
of internal friction-enhancing members 445 to assist in holding
suture 410 in a closed loop position after passing through at least
a portion of distal end 430. As further shown in FIGS. 4B and 4C,
external friction-enhancing members 425 and internal
friction-enhancing members 445 may take any shape, dimension or
contour capable of assisting with holding the suture in a closed
loop stitch. Suitable friction-enhancing members may also be formed
from any material capable of assisting in positioning at least a
portion of the proximal end of the suture within the inner hollow
region of the distal end of the suture.
[0035] It is envisioned that the sutures described herein may be
made of any suitable size, shape and dimension to close a wound in
living tissue. It is further envisioned that the sutures described
herein may be used to close a wound in any type of tissue. In
particularly useful embodiments, the sutures may be used to close
sub-dermal tissue, such as wounds common to plastic, laparoscopic
and general surgeries.
[0036] In embodiments, the sutures described herein may be used to
suture wounded tissues and form knotless wound closures. Methods of
suturing tissue include the steps of: providing a suture having a
proximal end with a first outer diameter and a distal end having an
inner hollow region with an inner diameter which is configured to
receive at least a portion of the first outer diameter of the
proximal end of the suture, passing the proximal end of the suture
through the tissue; and engaging the distal end of the suture with
at least a portion of the proximal end of the suture and forming a
closed loop. In embodiments, the closed loop can vary in size and
is adjustable to apply the appropriate amount of tension and force
to keep the wound closed.
[0037] The sutures described herein may be made using any known
method for forming a suture. Some non-limiting examples include,
molding, extruding, coextruding, and the like. In particular
embodiments, the sutures described herein may begin as a hollow
monofilament made of a suitable suture material. The distal end the
hollow suture is then expanded to allow the proximal end of the
suture to be received within the inner hollow region of the
expanded distal end of the suture. The distal end can be expanded
using any suitable method, including but not limited to, the use of
heat, pressure, physical force and any combination thereof. In
embodiments, a preformed tip may be positioned in the proximal end
of the hollow suture using any suitable means known to those
skilled in the art.
[0038] It will be understood that various modifications may be made
to the embodiments disclosed herein. Therefore, the above
description should not be construed as limiting, but merely as an
exemplification of preferred embodiments. Those skilled in the art
will envision other modifications within the scope and spirit of
the present disclosure. Various modifications and variations of the
suture and uses thereof will be apparent to those skilled in the
art from the foregoing detailed description. Such modifications and
variations are intended to come within the scope of the following
claims.
* * * * *